Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication HUMIRA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active r heumatoid a rthritis . FDA label
Adalimumab · 2 trials · 2 indications
The percentage of successful self-injections as reported in the questionnaires completed by the patients (Patient Assessment Tool, Question 1), analyzing all self-injections occurring after the trained self-injection. The higher the % the better the result.
The percentage of successful self-injections as reported in the questionnaires completed by the trial site personnel (Observer Assessment Tool, Question 1) , analyzing all self-injections occurring after the trained self-injection. The higher the % the better the result.
Percent (%) change in Psoriasis Area and Severity Index (PASI)
| Arm | Type | Description |
|---|---|---|
| Interventional, Single arm to evaluate autoinjector handling | OTHER | To assess the real-life patient handling experience with the use of an autoinjector in patients with moderate to severe active Rheumatoid Arthritis (RA) who selfinject AVT02 (adalimumab) subcutaneously (SC). |
| AVT02 100mg/mL (Adalimumab Biosimilar) | EXPERIMENTAL | Patients will be randomized to AVT02 on 1: 1 basis from the dosing day of Day 1 until week 48 |
| EU-Humira 100mg/mL (Adalimumab Originator) | EXPERIMENTAL | Patients will be randomized to EU-Humira on 1: 1 basis from the dosing day of Day 1 until week 48 |
| Name | Type | Description |
|---|---|---|
| Adalimumab | COMBINATION_PRODUCT | Combined product as Drug is delivered through an autoinjector pen on which real-life patient handling experience is assessed. |
Inclusion Criteria: * Patient is male or female, 18 to 80 years of age, inclusive, at time of Screening. * Patients diagnosed with RA for at least 4 months and currently classified according to the 2010 American College of Rheumatology (ACR)/ European League Against Rheumatism classification criter...
Adalimumab is used for plaque psoriasis and rheumatoid arthritis (RA). It is a monoclonal antibody developed by Alvotech as a biosimilar candidate referencing Humira. Alvotech is studying it in moderate-to-severe chronic plaque psoriasis and in RA, including real-life handling of an auto-injector presentation.
Adalimumab targets TNF, tumor necrosis factor. It is a monoclonal antibody that acts as a TNF inhibitor, binding TNF and blocking its inflammatory signaling. This mechanism underlies its development for immune-mediated conditions such as plaque psoriasis and rheumatoid arthritis.
Alvotech is developing adalimumab, under ticker ALVO. The company is advancing it as a biosimilar candidate referencing Humira, studied in plaque psoriasis and rheumatoid arthritis. Alvotech is the sponsor listed for the clinical program, which includes a Phase 3 study in moderate-to-severe chronic plaque psoriasis.
Adalimumab is in Phase 3 development. It is an investigational biosimilar candidate and is not described as approved. The program includes completed Phase 3 trials, one in moderate-to-severe chronic plaque psoriasis and one evaluating auto-injector real-life handling in rheumatoid arthritis patients.
Two completed Phase 3 trials are registered: NCT03849404, which assessed efficacy, safety, and immunogenicity of AVT02 in moderate-to-severe chronic plaque psoriasis across Estonia, Georgia, Poland, and Ukraine, and NCT04224194, which evaluated auto-injector real-life handling in rheumatoid arthritis patients in Georgia and Ukraine.
Adalimumab is also known as Adalimumab 100 MG/ML [Humira] and Adalimumab/ML. It is developed by Alvotech as a biosimilar candidate referencing Humira, meaning it is a proposed alternative version of adalimumab rather than the originator product itself.